Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma (SCC) of the Oral Cavity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Reflectance Confocal Microscopy — DEVICE
  Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.

Study Details

The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy." We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.

Key Dates

Start date

Jul 21, 2015

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

140 participants (estimated)

Arms

• Arm: SCC of the oral cavity scheduled for surgery
  The patients will be imaged for testing the feasibility of intra-oral imaging. Images will be compared to and evaluated against the corresponding pathology that is routinely prepared during surgery.

Primary Outcome Measure

Reflectance Confocal Microscopy (RCM) images [ Time Frame: 1 year ]

Central Contacts

• Snehal Patel, MD
  212-639-3412
• Milind Rajadhyaksha, PhD
  646-888-6243

Locations (5)

Find similar trials in Basking Ridge, NJ

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